A Clinical Follow-up Study of Heart Failure Patients.

• Conditions: Heart Failure

• Registration Number: NCT03797742
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

Heart failure (HF), a current worldwide pandemic with an unacceptable high level of morbidity and mortality, brings an enormous medical and societal burden. Chronic HF is characterized by progressive alteration of cardiac structure and function. But the molecular mechanism of these alterations is still not well-established and needs to be discussed further. HF is a highly heterogeneous disease that can be caused by a multiple of diseases. Dilated cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM) are the main causes of this syndrome. Although HF is the common manifestation of DCM and ICM, the etiology and pathogenesis are different. Understanding the different pathophysiological mechanisms will contribute to the prevention and individualized therapy of heart failure. Therefore, this study aims to observation the different characteristics of the molecular biology and clinical courses in DCM and ICM patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2019-01
• Study First Submitted: 2019-01-01
• Study First Submitted QC: 2019-01-08
• Last Update Submitted: 2019-01-08
• Study First Posted: 2019-01-09
• Last Update Posted: 2019-01-09
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• LVEF≤ 55%
• enlarged left ventricular end-diastolic dimension
• ICM group: with history of MI or revascularization; ≥ 75% stenosis of LM or proximal LAD; ≥ 75% stenosis of two or more epicardial vessels.
• symptomatic heart failure

Exclusion Criteria

• Known malignant tumour diseases
• Pregnancy or lactation period；
• Investigators think not suitable to participate in this trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NYHA functional class	one year after enrolled	NYHA cardiac functional class
All-cause mortality	one year after enrolled	All-cause mortality during follow-up

Secondary Outcome Measures

Name	Time	Method
hospitalization for cardiac causes	one year after enrolled	hospitalization for cardiac causes during follow-up
left ventricular end-diastolic dimension(LVEDD) dilates.	one year after enrolled	left ventricular structure changes:left ventricular end-diastolic dimension(LVEDD) dilates.
left ventricular ejection fraction reduces	one year after enrolled	left ventricular function changes:left ventricular ejection fraction reduces

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, China